The objective of this study is to compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis.

Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.

Bioequivalence [ Time Frame: Study day 90 (30 days after completion of 60 days of treatment) ] [ Designated as safety issue: No ]

Bioequivalence will be determined by evaluating the proportion of patients in the test and reference groups with 100% clearance of all AK lesions in the treatment area.

Secondary Outcome Measures:

Superiority to placebo [ Time Frame: Study day 90 (30 days after completion of 60 days of treatment) ] [ Designated as safety issue: No ]

The superiority of the test and reference gels against the placebo will be tested by the proportion of patients showing 100% clearance of actinic keratosis lesions at Day 90 (30 days after completion of 60 days of treatment)using the modified intent to treat population and last observation carried forward.

Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.

Diagnosis of AK with at least 5 and no more than 10 clinically typical, visable, discrete, nonhyperkeratotic, nonhypertrophic AK lesions each at least 4 mm in diameter on the face and/or bald scalp contained within a 25 cm2 treatment area.

Women either must be 1 year post-menopausal, surgically sterile, or if they are of child-bearing potential they must have been using systemic birth control, IUD or Norplant for at least 28 days prior to treatment start, or used barrier methods consistently at least 14 days before study gel administration, had a normal menstrual cycle for the month prior to the start of treatment, have a negative urine pregnancy test result upon entry into the study and agree to use a medically accepted form of birth control throughout the study period.

Free from any systemic or dermatologic disorder that, in the opinion of the investigator, will interfere with the study results or increase the risks of AEs.

Any skin type or race, providing the skin pigmentation will allow discernment of erythema.

Willingness and capability to cooperate to the extent and degree required by the protocol.

Any condition, medical, psychological or social, that, in the investigator's opinion, would interfere with participation in the study.

Women who are pregnant or planning pregnancy or lactating during the study.

Participation in any investigational drug study within 30 days of enrollment or previous participation in this study.

Employees or family members of employees of the research center or investigator.

Contacts and Locations

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